A Randomized Controlled Trial on the Effect of Hydroxychloroquine in Mild Graves' Orbitopathy

202101055MINB

This study is aimed to investigate the effect of hydroxychloroquine in patients with mild Graves' orbitopathy (GO).

2022-03-21

2024-12-31

2024-12-31

Recruiting

Early phase I

108

Inclusion Criteria: * Mild GO according European Group on Graves' orbitopathy (EUGOGO) guidelines diagnosed by endocrinologist and ophthalmologist. * No previous treatment of GO except for eyedrops * Euthyroidism (normalized free T4 and TSH) for at least 2 months. If radioactive iodine is used for hyperthyroidism, euthyroidism needs to be achieved for at least 6 months. Exclusion Criteria: * Moderate-to-sever or sight-threatening GO according to EUGOGO guidelines diagnosed by endocrinologist and ophthalmologist. * Pregnancy * Drug or alcohol abuse * Unable to comply with the study protocol * Unable to obtain informed consent * Use of hydroxychloroquine or systemic steroid within 3 months prior to enrollment * History of side effects of hydroxychloroquine * History of retinopathy * Renal dysfunction (estimated glomerular filtration rate (eGFR) \< 60ml/min) * Hepatic dysfunction (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2 x upper limit) * Anemia (hemoglobin (Hb) \< 10g/dl) * Neutropenia (absolute neutrophil count \< 100/uL) * Thrombocytopenia (platelet (PLT) \< 150000/uL) * Glucose-6-phosphate dehydrogenase (G6PD) deficiency * Porphyria cutaneous tarda * Allergy to 4-aminoquinoline

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 108, 'type': 'ESTIMATED'}}

2024-01-17